HealthyPhase 1NCT02686281
Safety and Pharmacokinetics Study of a New Drug for Type 2 Diabetes
A Phase 1 study testing GMC-252-L-Lysine in people with Healthy, run by Genmedica Therapeutics S.L. at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine the toxicity, tolerability and safety of single ascending doses of GMC-252-L-Lysine Salt in healthy male subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- GMC-252-L-Lysine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2012to Apr 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index (BMI) within the range of 18-35 kg/m2 inclusive. BMI = Body weight (kg) / [Height (m)]2.
- Diet: Able to eat standard food, no vegetarians.
- Compliance: Understood and was willing, able and likely to comply with all study procedures and restrictions.
- Consent: Demonstrated understanding of the study and willingness to participate as evidenced by voluntary written informed consent and had received a signed and dated copy of the Informed Consent Form.
- Had no known hypersensitivity to diflunisal, NAC (N-acetylcysteine) or other non-steroidal anti-inflammatory drugs (NSAIDs).
- Had no known peptic ulcer diseases.
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- Had an estimated creatinine (CREA) clearance ≥ 50 mL/min (Creatinine clearance was calculated from the serum CREA value using the Cockroft \& Gault formula).
- Had no history of heart failure or uncontrolled hypertension or other known overt cardiovascular disease.
- Had no history of 'Aspirin Triad' (chronic rhinosinusitis with polyps, severe asthma and intolerance to aspirin or other NSAIDs).
- Had no marked abnormality of liver tests before entry into the study.
- Male subject willing to use an effective method of contraception, if applicable (unless anatomically sterile or where abstaining from sexual intercourse was in line with the preferred and usual lifestyle of the subject) from Day 1 until 3 months afterwards.
- Subject with no clinically significant abnormal serum biochemistry, haematology and urine examination values at the Screening Visit.
- Subject with a negative urinary drugs of abuse screen (a positive alcohol result could have been repeated at the discretion of the Investigator).
- Subject with negative human immunodeficiency virus (HIV) and Hepatitis B (Hep B) and Hepatitis C (Hep C) results.
- Subject with no clinically significant abnormalities in 12-lead ECG at the Screening Visit.
- Subject was available to complete the study (including all Follow-up Visits).
- Subject satisfied a medical examiner about their fitness to participate in the study.
- Subjects were non-smokers and non-alcohol drinkers or drank alcohol in moderation (e.g. ≤ 14 units/week).
Who cannot join
- A clinically significant history of gastrointestinal disorder likely to influence drug absorption.
- Receipt of regular medication at the Screening Visit that may have had an impact on the safety and objectives of the study (at the Investigator's discretion).
- Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
- A clinically significant history of previous allergy/sensitivity to GMC-252.
- A clinically significant history of drug or alcohol abuse.
- Inability to communicate well with the Investigator (i.e., language problem, poor mental development or impaired cerebral function).
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- Participation in a New Chemical Entity clinical study within the previous 16 weeks or a marketed drug clinical study within the previous 12 weeks. (N.B. washout period between trials defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study).
- Donation of 450 mL or more blood within the previous 12 weeks.
- Receipt of any medication since the Screening Visit that may have had an impact on the safety and objectives of the study (at the Investigator's discretion).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Placebo-Controlled, Randomised, Two Part Study of the Safety and Pharmacokinetics of GMC-252 in A) Healthy Male Subjects, Including a Comparison of GMC-252 Dosing in the Fed and Fasted States ,and B) in Subjects With Type 2 Diabetes Mellitus
The purpose of this study is to determine the toxicity, tolerability and safety of single ascending doses of GMC-252-L-Lysine Salt in healthy male subjects.
- Conditions
- Healthy
- Being tested
- GMC-252-L-Lysine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GMC-252-L-LysineDrug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Cohort A (Part A) | Experimental | Single ascending oral administrations of GMC-252-L-Lysine Salt and matching placebo
Interventions:
Drug: GMC-252-L-Lysine Other: Placebo Receives: Drug: GMC-252-L-Lysine; Other: Placebo |
| Cohort B (Part A) | Experimental | Single ascending oral administrations of GMC-252-L-Lysine Salt and matching placebo
Interventions:
Drug: GMC-252-L-Lysine Other: Placebo
The dose administered in Part A (fed) was based on the outcome of Part A (fasted). Receives: Drug: GMC-252-L-Lysine; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Serious and Non-Serious Adverse Events
Physical status (Vital signs; 12-lead ECG; Urinalysis; Haematology and biochemistry)
Measured: Over a 14 days period post dose
Secondary outcomes (2)
Maximal Concentration (Cmax)
Measured: Over a 14 days period post dose
Area Under the Concentration-Time Curve
Measured: Over a 14 days period post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2016 (estimated)
- Study startSep 2012
- Primary completionJul 2013
- Study completionApr 2014
Why it stopped: Business reason
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genmedica Therapeutics S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Simbec Research
- Responsible party
- Sponsor
- Investigators
- Salvatore Febbraro, MBBS, Principal investigator, Simbec Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02686281
- Sponsor's protocol ID
- GMC-252-1.02
- Status last verified
- Apr 2016
- First submitted
- 10 Feb 2016
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Randomised, Two Part Study of the Safety and Pharmacokinetics of GMC-252 in A) Healthy Male Subjects, Including a Comparison of GMC-252 Dosing in the Fed and Fasted States ,and B) in Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02686281
- Acronym / sponsor ID
- GMC-252-1.02
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business reason
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Genmedica Therapeutics S.L.Industry (pharma, biotech, devices)
- Collaborators
- Simbec Research
- Study start
- Sep 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 19 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the toxicity, tolerability and safety of single ascending doses of GMC-252-L-Lysine Salt in healthy male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A (Part A) | Experimental | Drug: GMC-252-L-Lysine, Other: PlaceboSingle ascending oral administrations of GMC-252-L-Lysine Salt and matching placebo Interventions: Drug: GMC-252-L-Lysine Other: Placebo |
| Cohort B (Part A) | Experimental | Drug: GMC-252-L-Lysine, Other: PlaceboSingle ascending oral administrations of GMC-252-L-Lysine Salt and matching placebo Interventions: Drug: GMC-252-L-Lysine Other: Placebo The dose administered in Part A (fed) was based on the outcome of Part A (fasted). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Body Mass Index (BMI) within the range of 18-35 kg/m2 inclusive. BMI = Body weight (kg) / [Height (m)]2.
- Diet: Able to eat standard food, no vegetarians.
- Compliance: Understood and was willing, able and likely to comply with all study procedures and restrictions.
- Consent: Demonstrated understanding of the study and willingness to participate as evidenced by voluntary written informed consent and had received a signed and dated copy of the Informed Consent Form.
- Had no known hypersensitivity to diflunisal, NAC (N-acetylcysteine) or other non-steroidal anti-inflammatory drugs (NSAIDs).
Key exclusion criteria (9 listed)
- A clinically significant history of gastrointestinal disorder likely to influence drug absorption.
- Receipt of regular medication at the Screening Visit that may have had an impact on the safety and objectives of the study (at the Investigator's discretion).
- Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
- A clinically significant history of previous allergy/sensitivity to GMC-252.
- A clinically significant history of drug or alcohol abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GMC-252-L-Lysine | Drug | Cohort A (Part A), Cohort B (Part A) |
| Placebo | Other | Cohort A (Part A), Cohort B (Part A) |
Primary outcome
Number of Participants with Serious and Non-Serious Adverse Events
Time frame: Over a 14 days period post dose
Physical status (Vital signs; 12-lead ECG; Urinalysis; Haematology and biochemistry)
2 secondary outcomes
Maximal Concentration (Cmax)
Time frame: Over a 14 days period post dose
Area Under the Concentration-Time Curve
Time frame: Over a 14 days period post dose
Results and safety
The study was stopped early (reason given: Business reason). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salvatore Febbraro, MBBS principal investigator
Simbec Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GMC-252-L-Lysine in people with Healthy, run by Genmedica Therapeutics S.L. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Business reason). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Serious and Non-Serious Adverse Events (time frame: Over a 14 days period post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2016.